ALPHA MX (20)/ULTRA PC (30)

K970163 · Technical Medical Products, Inc. · BSZ · Dec 10, 1997 · Anesthesiology

Device Facts

• Record ID: K970163
• Device Name: ALPHA MX (20)/ULTRA PC (30)
• Applicant: Technical Medical Products, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Dec 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This anagelsia gas machine is to be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.

Device Story

Alpha MX (Model 20) and Ultra PC (Model 30) are gas machines for analgesia; designed for delivery of nitrous oxide/oxygen mixtures to patients. Devices function as part of sedation systems; limit nitrous oxide concentration to maximum 70%. Used in clinical settings by healthcare professionals for patient sedation. Output is controlled gas mixture for analgesic effect.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gas machine for analgesia; delivers nitrous oxide/oxygen mixture; maximum 70% nitrous oxide concentration. Mechanical gas delivery system.

Indications for Use

Indicated for patients requiring nitrous oxide/oxygen sedation. Limits maximum nitrous oxide concentration to 70%.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Rockville MD 20857

DEC 10 1997

Mr. James R. Moore
Technical Medical Products, Inc.
2020 West Melinda Lane
Phoenix, Arizona 85027

Re: K970163
Model 20 Alpha MX Gas Machine for Analgesia and Model 30 Ultra PC Gas Machine for Analgesia
Regulatory Class: II (two)
Product Code: 73 ELI
Dated: September 12, 1997
Received: September 15, 1997

Dear Mr. Moore:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}

Page 2 - Mr. James R. Moore

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{2}

510(k) Notification
September 12, 1997
Technical Medical Products, Inc.
Models 20 & 30 N2O-O2 Anagelsia gas machines

510(k) Number if Known: K970163

Device Name:

**Classification Name** - Gas machine for analgesia

**Trade Name**

Alpha MX Anagelsia gas machine
Model 20

Ultra PC Anagelsia gas machine
Model 30

Indications for Use:

This anagelsia gas machine is to be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970163

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-the-Counter-Use

12